Sammenligning Mellem Standard Tube og Den Ultra-tynde Tritube® Til Intubation, og Til Opretholdelse af Adgang Til Trachea Efter anæstesi, Hos Patienter Med Forventet Vanskelig Direkte Laryngoskopi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Rate of Excellent intubation conditions
研究概览
简要总结
The investigators compare the ease of intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter.
详细描述
In patients scheduled for surgery and anaesthesia in the Head-/neck/ear/nose/throat -region the investigators compare the ease of tracheal intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. The intubation is performed with an angulated video laryngoscope.
Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter. The latter continues into the post-operative recovery-ward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for anaesthesia for surgery in the Head-/neck/ear/nose/throat
- •planned for oral intubation with video-laryngoscopy
- •with risk factors for difficult direct laryngoscopy
排除标准
- •Patient with increased secretions in the airway (Pneumonia, bronchitis, productive cough)
- •Patients planned for awake intubation
- •Patients where mask-ventilation is judged to could become impossible
- •Patients where access to the cricothyroid membrane is judged to be difficult or impossible
- •Patients in ASA (american Society of Anaesthesiologists) physical classification status >3
- •Patients who are scheduled for rapid sequence induction (RSI) due to risk of aspiration
- •Patients with stridor
- •Patients with hypoxemia (Saturation < 90 % in room air)
- •Operation duration planned to > 2.5 hours
- •Patients with the need for a nerve-stimulation-tube during surgery
结局指标
主要结局
Rate of Excellent intubation conditions
时间窗: 2 hours
Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor
次要结局
- Number of intubation attempts(2 hours)
- the "percent of glottic opening" , (POGO), Before the tube is inserted(2 hours)
- The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation(2 hours)
- The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery(20 minutes)
- The patient's satisfaction with having the Tritube or the tube-exchange-catheter in place when being awake in the Post anaesthesia care unit(4 hours)
- The rate of succesful intubation with 60 seconds(1 minute)
- Number of remodellings of the stilette(2 hours)
- rate of use for "reverse loading" of the tube on the stylet(2 hours)
- Intubation conditions Strom scale(2 hours)
- The ration of patients who still has the Tritube or the tube-exchange-catheter in place when arriving in the post-operative recovery unit(4 hours)
- The Intubation Difficulty Score (IDS)(2 hours)
- the"percent of glottic opening" , POGO, with the tube in place(2 hors)
- the duration of the Tritube being in the trachea after return of spontaneous ventilation and deflation of the cuff /(Tritube group)(4 hours)
- The ration of patients who still has the Tritube or the tube-exchange-catheter in place one hour after arrival in the Post anaesthesia care unit the post-operative recovery unit(4 hours)
- The rate of interruption by the tube of the view to the vocal cords at any time, to such a degree that it disturbs the intubation(2 hours)
- Time to intubated(2 hours)
- Time to the patient becomes ventilated via the tube(2 hours)
- The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group)(4 hours)
研究者
Michael Seltz Kristensen
Principal Investigator
Rigshospitalet, Denmark